They Said It!: Lawmakers And FDA Nominee Highlight Greater Competition As Critical To Lowering Prescription Drug Prices

Mar 12, 2025

U.S. Senate Confirmation Hearing Called Attention to Big Pharma’s Egregious Patent Abuse and Price Hikes

On Thursday, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) held a confirmation hearing for Dr. Martin Makary’s nomination to serve as Commissioner of the U.S. Food and Drug Administration (FDA). During the hearing, Dr. Makary and lawmakers from both parties discussed the importance of supporting greater biosimilar and generic competition to help lower prescription drug prices, including by addressing Big Pharma’s abuse of the patent system.

In response to a question from U.S. Senator Maggie Hassan (D-NH), where she noted Big Pharma has already hiked prices on more than 500 prescription drugs so far this year, Dr. Makary pointed to cracking down on patent abuse as critical for fostering more competition in the market. “I would love to work with Congress to address the way that patent law has enabled patent thicketing, which makes it more difficult for biosimilars and even some generics to come to market because they got to navigate so many lawsuits and letter of the patent law,” he said.

During the hearing, U.S. Senator Susan Collins (R-ME) also emphasized the importance of greater competition from more affordable alternatives, saying, “one of the best ways to lower the cost of prescription drugs is by promoting more market competition. And one way that we can do this is by making it easier for generic and biosimilar drugs to come to the market.”

In response, Dr. Makary agreed, stating, “I am a big believer that we need to figure out a way to get biosimilars approved quicker without cutting corners on the scientific review, and it is one of several strategies that the FDA can do to try to alleviate the problems of high drug prices.”

The Cost of Big Pharma’s Patent Thickets and Solutions to Boost Competition

A January 2023 report from Matrix Global Advisors, “Patent Thickets and Lost Drug Savings,” quantified the one-year cost of lost savings on five brand name drugs around which Big Pharma has built especially egregious patent thickets. The five drugs were AbbVie’s autoimmune drug Humira and oncology drug Imbruvica, Regeneron’s ophthalmology drug Eylea, Amgen’s autoimmune drug Enbrel and Bristol Myers Squibb’s oncology drug Opdivo.

The report assesses what the savings would be for these five drugs if “a steady state of competition [existed] where generics and biosimilars have achieved price discounts and uptake currently observed in the market.” Based on these calculations, the estimated one-year cost of patent thickets on each of these brand name drugs was:

$7.6 billion for Humira
$3.1 billion for Imbruvica
$2.5 billion for Eylea
$1.9 billion for Enbrel
$1.8 billion for Opdivo

This amounts to a total of more than $16 billion in additional drug spending each year for just these five brand name drugs.

Policymakers in Washington can crack down on Big Pharma’s patent abuse and foster greater competition in the market to lower drug prices for consumers by building on bipartisan momentum for market-based solutions introduced in the last Congress, including the unanimous U.S. Senate passage of Cornyn-Blumenthal (S.150) in July 2024. The bill would hold Big Pharma accountable for patent thickets that block competition from more affordable alternatives and impose billions of dollars in higher drug costs on patients and the U.S. health care system each year. The nonpartisan Congressional Budget Office (CBO) estimated the bill, in the version passed by the Senate, would save $1.8 billion.

Reforming the FDA’s Q1/Q2 Requirements to Prevent Big Pharma From Abusing the System to Block or Delay Generic Drugs from Entering the Market

Another way Big Pharma games the system to block competition from more affordable alternatives to high-priced brand name drugs concerns a process known as “Q1/Q2 sameness,” which refers to a requirement from the FDA that “generic drug manufacturers mimic the brand-name drug formulation for certain formulations” so that these drugs are “qualitatively the same, or Q1,” meaning they contain the “same inactive ingredients,” and that they are also “quantitively the same, or Q2,” in that they have “essentially the same concentration” of these ingredients.

The problem arises in the fact that brand name drug makers can assert “trade secret protection” around many of the products generic drug makers are attempting to copy, meaning generic drug manufacturers have to “essentially play a protracted guessing game with FDA.” As Association for Accessible Medicines (AAM) CEO John Murphy III wrote in a recent column, this leads to “a lot of spilled ink, wasted resources and unnecessary red tape,” and has “delayed generic competition, and in particular competition for critical complex products—a growing category of medicines that have complex active ingredients, formulations, or routes of administration—that are frequently expensive and desperately require generic competition.”

According to AAM, Q1/Q2 reforms would “save the U.S. healthcare system nearly $900 million over 10 years and bring lower-cost medicines to patients sooner.”

Listen to the full hearing HERE.

Read more on Big Pharma’s patent abuse that blocks competition and keeps prices high HERE.

Read more on how Big Pharma’s patent abuse tactics drive increased costs for consumers and the U.S. health care system HERE.